KR20210077717A - Pre-Filled Safety Needle and Syringe System - Google Patents

Abstract

A needle and pre-filled syringe system (10) is provided that provides ultra-low waste and automatic needle protection. The syringe system 12 is pre-filled with material 15 . The needle head assembly 14 is attached to the syringe assembly 12 . A spacer 54 is disposed between the needle head assembly 14 and the syringe assembly 12 . Spacer 54 includes a central opening 56 . The needle head assembly 914 supports a needle 16 that includes a needle base 20 . When assembled, the needle base 20 passes inside the central opening 56 of the spacer 54 . The needle head assembly 914 also includes a safety slide 22 that can optionally cover the needle 16 . During injection, pressure and/or contact with the plunger head 52 causes the spacer 54 to contact the safety slide 22 and cause it to move. A safety slide 22 moves to cover and secure the needle 16 during the injection process.

Description

Pre-Filled Safety Needle and Syringe System

In general, the present invention relates to a pre-filled syringe used for injection through a needle or cannula. More particularly, the present invention relates to needle and syringe systems in which the needle is automatically shielded after use.

Millions of injections are administered each year in the United States. Injections are generally performed using a hypodermic needle and syringe. The length of the hypodermic needle and the gauge of the needle depend on the field of application and whether the injection is intramuscular, subcutaneous, intravenous or intradermal. The compounds to be injected also vary widely. Many pharmaceutical compounds, such as certain gene therapy compounds, can cost tens of thousands of dollars per injection. As such, a fraction of a milliliter of pharmaceutical can be worth hundreds of dollars.

Some pharmaceutical compounds are prepared in pre-filled syringes. That is, the exact dose of the pharmaceutical compound is filled into the syringe by the manufacturer. The syringe is sealed and sent to the healthcare provider. The healthcare provider attaches the needle head to the pre-filled syringe and administers the injection to the patient. When an existing needle head is used to perform injection, a certain space occupied by the injection material remaining in the needle head after the injection is completed inevitably exists. Thus, the entire dose contained within the pre-filled syringe is not delivered to the patient. Any pharmaceutical material remaining in the needle head after injection is discarded. This wasted pharmaceutical substance adds billions of dollars to wasted pharmaceuticals when all injections are taken into account.

In the prior art, little consideration is given to the volume of residual material essentially remaining on the inside of the needle head. Some needle and syringe assemblies are designed such that the syringe plunger and the needle head are in flush contact. This prior art is described in Lee's U.S. Patent No. 6,616,636 and Jentzen's U.S. Patent No. 5,902,270. However, in real medical environments such as hospitals, pre-filled syringes are used with various needle heads depending on the injection being made. Some needle head and syringe combinations are efficient at evacuating pharmaceutical compounds, while some are not.

The problem is further complicated when the needle head used in pre-filled syringes includes a safety feature. Some needle heads are designed to provide some mechanism for performing injections and minimizing the possibility of needlestick injury. Needle stab wounds are common among healthcare workers. Needle stab wounds are classified by the National Institute of Occupational Safety of Health as a hypodermic needle, a blood collection needle, an intravenous (IV) stylet, and injuries caused by needles, such as needles used to connect parts of an IV delivery system. Needle cuts can transmit blood-borne pathogens such as hepatitis B virus, hepatitis C virus, and human immunodeficiency virus (HIV). For healthcare workers, needle puncture is the cause of a significant proportion of these ailments in healthcare workers.

The Center for Disease Control estimates that more than 3 million health care workers in the United States are exposed to blood and body fluids from needle accidents each year. Most health care workers are trained in needle use and disposal procedures. Used needles should not be recaptured to avoid the possibility of needle puncture. However, many studies reveal that recap is still prevalent among healthcare workers.

In order to reduce the number of needle cuts, various safety needles have been developed that serve to cover the needle as soon as it emerges from the skin. This is generally done by advancing the tubular sheath along the shaft of the needle until the sheath covers the tip of the needle. This prior art is described in Berler's U.S. Patent No. 6,626,863, Berler, U.S. Patent Application Publication No. 2007/0016140, Berler, U.S. Patent Application Publication No. 2007/0016145, Berler, U.S. Patent Application Publication No. 2008/009808. However, additional space is generally required on the inside of the needle head to incorporate a safety mechanism on the inside of the needle head. More space on the inside of the needle head means more dead space in the needle head where residual pharmaceutical compound can collect. As a result, there is often the opposite problem of having to balance the design. The safety function of the design is contrasted with the wasted constraints left behind by the safety function.

Accordingly, there is a need for improved hypodermic needles and pre-filled syringe assemblies in which the needle is automatically shielded after injection and the assembly does not leave a significant amount of injected material.

This need is met by the invention described and claimed below.

The present invention is a needle and pre-filled syringe system that provides both ultra-low dosage waste and automatic needle protection. A syringe assembly is provided that includes a syringe barrel and a plunger. The syringe barrel is pre-filled with injection material. The plunger includes a plunger head that moves on the inside of the barrel and can be used to move the injectable material towards the open end of the syringe barrel.

Prior to use, the needle head assembly is attached to the syringe assembly. A spacer is disposed between the needle head assembly and the syringe assembly. The spacer includes a central opening extending through the spacer.

The needle head assembly supports a needle including a needle base. The needle head assembly is attached to the syringe barrel over the open end of the syringe barrel. When assembled, the needle base passes into the center opening of the spacer. The needle head assembly also includes a safety slide that can optionally cover the needle. During injection, pressure and/or contact with the plunger head causes the spacer to contact and move the safety slide. As such, the safety slide moves to cover the needle during the injection process and secures the needle even before the injection process is complete.

For a better understanding of the present invention, reference is made to the following description of exemplary embodiments of the present invention considered in connection with the accompanying drawings below:
1 is a cross-sectional view of a safety needle and syringe system according to an exemplary embodiment including a syringe assembly attached to a needle head assembly;
Fig. 2 is an exploded view of the exemplary embodiment of Fig. 1;
3 is a perspective view of the safety slide component of the needle head assembly;
4 is an enlarged cross-sectional view of the needle head assembly and the neck portion of the syringe assembly before the safety slide of the needle head assembly is actuated;
5 is an enlarged cross-sectional view of the needle head assembly and the neck portion of the syringe assembly while the safety slide of the needle head assembly is actuated;
6 is an enlarged cross-sectional view of the needle head assembly and the neck portion of the syringe assembly after the safety slide of the needle head assembly has been actuated; And
7 is a cross-sectional view of a needle and pre-filled syringe assembly according to another embodiment.

The needle and syringe systems of the present invention may be configured in a variety of ways and may be configured for use in many applications. However, only a few exemplary embodiments are selected for purposes of explanation and illustration. However, the illustrated embodiments are illustrative only and are not to be considered limiting when interpreting the scope of the appended claims.

1, 2 and 3, an overview of a needle and syringe system 10 of the present invention is shown. In the illustrated embodiment, the needle and syringe system 10 includes two primary assemblies that are selectively joined by a healthcare professional immediately prior to use. The primary assembly includes a pre-filled syringe assembly 12 and a needle head assembly 14 .

The pre-filled syringe assembly 12 contains an amount of injection material 15 that is sealed to the inside of the pre-filled syringe assembly 12 . When the needle head assembly 14 is attached to the pre-filled syringe assembly 12, the needle head assembly 14 passes through the pre-filled syringe assembly 12, and the injection material 15 and the hypodermic injection needle ( 16) to provide a flow path between them. More specifically, the needle 16 is surrounded by a sheathing tube 30 . During the injection procedure, the sheath tube 30 is advanced over the needle 16, making the needle 16 secure even before it is withdrawn from the patient. Thus, the needle 16 is exposed prior to the injection procedure ( FIG. 1 ) and covered at the end of the injection procedure ( FIG. 2 ).

Referring to FIGS. 4 and 5 in conjunction with FIG. 3 , the needle head assembly 14 can be understood to hold the needle 16 . The needle 16 includes a first sharp end 18 and an opposing second end 19 . Both ends 18 , 19 protrude from the needle head assembly 15 in opposite directions. The gauge of the needle 16 and the length of the needle 16 are selected by medical professionals for the medical procedure being performed. On the inside of the needle head assembly 14 , a portion of the needle 16 is disposed on the inside of an elongated base 20 . The elongated base 20 is tubular and does not impede flow through the needle 16 . As such, the needle 16 and the elongated base 20 move together as a single unit. The second end 19 of the needle 16 may end at the same point as the elongate base 20 as shown. However, for cost savings, the needle 16 may end on the inside of the long base 20 , and the long base 20 may continue to extend in the same direction as the needle 16 to the point of protrusion.

The needle head assembly 14 includes a collar 34 and a safety slide 22 . The long base 20 of the needle 16 is attached to a collar 34 . As such, during injection, there is no relative movement between the collar 34 , the needle 16 , and the elongated base 20 . The collar 34 is mechanically attached to the pre-filled syringe assembly 12 via a bayonet connection, screw connection, or similar mechanical connection. As such, the collar 34 is used to interconnect the needle head assembly 14 to the pre-filled syringe assembly 12 . The collar 34 includes an internal ridge 35, the purpose of which will be described below.

A safety slide 22 is disposed on the interior of the collar 34 , where the safety slide 22 surrounds a portion of the needle 16 and the elongated base 20 . Safety slide 22 moves relative to needle 16 and collar 34 , where needle 16 and collar 34 guide the movement of safety slide 22 .

The safety slide 22 includes a tubular body 24 . Legs 26 extend from a first end 27 of the tubular body 24 . The locking projection 38 extends radially from the leg 26, the purpose of which will be described later. The tubular body 24 defines a central cavity 28 sized to receive the elongate base 20 of the needle 16 . The sheath tube 30 extends from the second end 31 of the safety slide 22 opposite the leg 26 . The extended sheathing tube 30 is of a cantilever structure and forms a path in communication with the central cavity 28 . The elongated base 20 extends inside the central cavity 28 of the safety slide 22 , and the needle 16 extends through the sheath tube 30 of the safety slide 22 . As will be explained, the safety slide 22 is movable relative to the needle 16 and the elongated base 20 .

The pre-filled syringe assembly 12 includes a barrel 40 . The barrel 40 defines a tubular chamber 41 extending between the first open end 42 and the second open end 44 . The barrel 40 may be glass or plastic. In the illustrated embodiment, the barrel 40 includes a threaded neck 47 . As such, the inner diameter of the barrel 40 is reduced upon conversion to the threaded neck 47 . The threaded neck 47 is threaded or configured to engage the collar 34 of the needle head assembly 14 . Likewise, the outside of the barrel 40 at the opposite second end 44 includes a finger flange 46 to facilitate proper gripping of the pre-filled syringe assembly 12 .

A plunger 50 is disposed inside the barrel 40 . The plunger 50 includes a plunger head 52 that seals the tubular chamber 41 on the inside of the barrel 40 when the plunger 50 reciprocates inside the barrel 40 . The plunger head 52 is wider than the threaded neck 47 of the barrel 40 and cannot pass through the threaded neck 47 . The plunger head 52 includes a face surface 55 facing the first open end 42 of the barrel 40 .

A tubular spacer 54 is disposed inside the tubular chamber 41 of the barrel 40 . The tubular spacer 54 includes a central opening 56 extending between a first end 57 and a second end 58 . The tubular spacer 54 includes a narrow portion 63 and an enlarged base 64 . The expanded base 64 has the same diameter as the plunger head 52 and seals the tubular chamber 41 on the inside of the barrel 40 in the same way. As such, the fluid can only pass through the tubular spacer 54 on the inside of the barrel 40 by flowing through the central opening 45 extending through the tubular spacer 54 . The first end 57 of the tubular spacer 54 is oriented towards the face surface 55 of the plunger head 52 . The first end 57 of the tubular spacer 54 is configured to abut the plunger head 54 with no gap space therebetween. At the opposite second end 58 , the central opening 56 of the tubular spacer 54 is sized to receive the elongate base 20 under the needle 16 .

The tubular spacer 54 is disposed inside the tubular chamber 41 of the barrel 40 . Initially, the second end 58 of the tubular spacer 54 is flush with the first open end 42 of the barrel 40 . The expanded base 64 of the tubular spacer 54 forms a seal on the inside of the barrel 40 . A volume of injection material 15 is added to the barrel 40 , and the injection material 15 is disposed between the plunger head 52 and the tubular spacer 54 . As the plunger head 52 advances inside the barrel 40 , the only exit of the filler material 15 is through the central opening 56 of the tubular spacer 54 . A seal cover 67 is provided to seal the central opening 56 of the tubular spacer 54 and the first open end 42 of the barrel 40 . As such, prior to use, it can be understood that both the filler material 62 and the tubular spacer 54 are sealed to the inside of the barrel 40 .

Referring to FIG. 6 in conjunction with FIGS. 4 and 5 , when the needle head assembly 14 is attached to the pre-filled syringe assembly 12 , the second end 19 of the needle 16 and/or the needle It can be understood that the elongated base 20 of 16 passes through the seal cover 67 on the pre-filled syringe assembly 12 . This occurs when the collar 34 of the needle head assembly 14 is attached to the threaded neck 47 of the barrel 40 . As the seal cover 67 is pierced, the elongated base 20 of the needle 16 passes inside the central opening 56 of the tubular spacer 54 . The elongated base 20 passes inside the tubular spacer 54 in an interference fit, forming a fluid impermeable seal between the elongated base 20 and the tubular spacer 54 . As a result, the only exit of the infusion material 15 is through the central opening 56 of the tubular spacer 54 and through the needle 16 .

It will be appreciated that, for use with the needle and syringe system 10 , the needle head assembly 14 and the syringe assembly 12 are selected to be suitable for performing medical injections. The needle head assembly 14 is manually attached to the pre-filled syringe assembly 12 . The correct amount of injectable material 15 is contained inside the pre-filled syringe assembly 12 .

Prior to use, the sharp first end 18 of the needle 16 is exposed. The first end 18 of the needle 16 is used to inject through the skin of the patient. Because the sheath tube 30 is thin, the sheath tube 30 also passes into the skin, generally through an orifice formed by the needle 16 . The injection material 62 is injected by advancing the plunger head 52 towards the needle head assembly 14 . 5 and 6 sequentially, the needle 16 and the elongated base 20 remain stationary before, during, and after the injection. The elongated base 20 extends partially inward of the central opening 56 of the tubular spacer 54 . In this way, the injection material 15 flowing through the needle 16 can freely flow through the tubular spacer 54 .

As the plunger 50 advances inside the barrel 40 , the injection material 15 is discharged out of the barrel 40 through the needle 16 . As the plunger head 52 first contacts the tubular space 54 , there is no gap space between the plunger head 52 and the tubular spacer 54 . The only area containing the injection compound 62 is inside the needle 16 and inside the central opening 56 of the tubular spacer 54 not occupied by the elongated base 20 of the needle 16 . However, at this point, the plunger 50 has not yet been fully depressed on the inside of the barrel 40 .

Referring to FIG. 6 , as the plunger 50 advances, it can be seen that the pressure of the injection material begins to push the tubular spacer 54 into the needle head assembly 14 . At the end of the injection process, the plunger head 52 contacts the tubular spacer 54 and pushes it directly. At this point, there is very little opening space inside the tubular spacer 54 . The only space for the injection material 15 to remain is inside the needle 16 itself. This area is very small. As a result, the injectable material 15 is not wasted and almost all of the injectable material 15 contained inside the pre-filled syringe assembly 12 is discharged during the injection process.

As the tubular spacer 54 is advanced out of the barrel 40 by the plunger head 52 , the tubular spacer 54 presses against the legs 26 of the safety slide 22 . As a result, the safety slide 22 is pressed on the inside of the peripheral collar 34 and moves forward. As the safety slide 22 moves forward, the sheath tube 30 advances over the needle 16 , which eventually extends beyond the sharp first end 18 of the needle 16 . . Movement of the safety slide 22 occurs during the injection procedure. The passage of the sheathing tube 30 onto the tip of the needle 16 generally occurs prior to completion of the injection. As such, when the needle 16 comes out of the skin, the needle 16 is already covered by the covering tube 30 . This makes the needle 16 safe.

As the safety slide 22 advances on the inside of the secured collar 34 , the locking protrusions 38 on the legs 26 of the safety slide 22 engage the inner ridge 35 on the inside of the collar 34 . it is connected to it This prevents the needle head assembly 14 from being reset and reused. In addition, as the safety slide 22 advances on the inside of the collar 34, a visual indicator 65 (FIG. 3) on the outside of the safety slide 22 becomes visible. The visual indicator 65 becomes visible as the safety slide 22 engages and locks the collar 34 . The visual indicator 65 allows the healthcare practitioner to know that the needle and syringe system 10 has been used and that the system 10 is locked in a secure state and ready for disposal.

In view of the above,

Prior to use, the safety slide 22 is retracted and the needle 16 is extended beyond the sheath tube 30 so that it can be used. In use, the safety slide 22 advances the sheath tube 30 along the needle 16 to cover the needle 16 . After use, the safety slide 22 is fully extended and the sheath tube 30 completely covers the needle 16 and secures the needle 16 .

1-6 , the needle and pre-filled syringe system 10 is applied to a syringe barrel 40 having a narrow threaded neck 47 . This is common in glass syringe barrels. However, in the case of plastic syringe barrels, the barrel often has a constant diameter between the ends. Referring to FIG. 7 , a pre-filled syringe assembly 70 is shown that includes a constant diameter barrel 72 . A ring projection 74 is formed on the inside of the barrel 72 at a short distance from the open end 76 . An elastomeric seal 78 is disposed on the inside of the barrel 72 , and the elastic seal 78 overlies the ring protrusion 74 . The elastic seal 78 is protected by a peel-away cover 79 .

The same needle head assembly 70 as described above is provided. However, in this embodiment, the tubular spacer 82 is disposed on the inside of the needle head assembly 80 rather than the inside of the pre-filled syringe assembly 70 . When the needle head assembly 80 is attached to the pre-filled syringe assembly 70 , the needle head assembly 80 penetrates the resilient thread 78 of the pre-filled syringe assembly 70 . As the plunger 84 moves, the elastic seal 78 moves relative to the tubular spacer 82, and the two components act as a single element. The tubular spacer 82 then activates the safety function implemented on the inside of the needle head assembly 80 in the same manner as described above with respect to the first embodiment.

It will be understood that the embodiments of the present invention illustrated and described are merely exemplary and that those skilled in the art may make many modifications to these embodiments. All such embodiments are intended to be included within the scope of the invention as defined by the claims.

Claims (18)

a syringe barrel (40) pre-filled with injection material (15), said syringe barrel (40) comprising a first open end (42);
A plunger ( 50 ) including a plunger head ( 52 ) capable of reciprocating inside the syringe barrel ( 40 ), the plunger head ( 52 ) is located inside the syringe barrel ( 40 ). comprising a face surface 55 facing the injection material 15;
A spacer 54 disposed in the syringe barrel 40 , the spacer 54 has a central opening 56 extending through the spacer 54 and an injection material 15 on the inside of the syringe barrel 40 . ) comprising a contact surface 57 ;
A seal (67) closing the first open end (42) of the syringe barrel (40), the injection material (15) and the spacer (54) are located inside the syringe barrel (40) and the plunger head (40) interposed between (52) and said thread (67); and
A needle head assembly (14) supporting a needle (16), the needle head assembly (14) optionally attached to the syringe barrel (40) above the first open end (42), the needle head assembly (14) is interconnected with the spacer (54) such that the central opening (56) of the spacer (54) is aligned with the needle (16) through the thread (67);
A needle and syringe system (10) comprising: According to claim 1,
The needle head assembly (14) includes a needle base (20) for supporting the needle (16), and a collar (34) optionally connected to the syringe barrel (40), the needle base (20) ) is the system attached to the collar (34). 3. The method of claim 2,
A system in which the needle base (20) extends inwardly of the central opening (56) of the spacer (54) as the collar (34) is connected to the syringe barrel (40). 4. The method of claim 3,
The needle (16) extends between a first sharp end (18) and an opposing second end (19), and as the needle head assembly (14) is attached to the syringe barrel (40), the needle (16) The second end (19) of the system passes through the seal (67). 3. The method of claim 2,
and a safety slide (22) comprising a sheathing tube (30) surrounding a portion of the needle (16), wherein the safety slide (22) is configured such that the sheathing tube (30) is connected to the needle (16). ) and a second position in which the sheath tube (30) covers the entirety of the needle (16) and is movable relative to the needle (16) and the collar (34). 6. The method of claim 5,
When the plunger 50 is advanced in the syringe barrel 40 , the plunger head 52 contacts and moves the spacer 54 , and the spacer 54 moves over the needle base 20 . advancing, and the safety slide (22) moves from the first position to the second position. 7. The method of claim 6,
As the safety slide 22 moves from the first position to the second position, the needle base 20 moves inside the spacer 54 through the central opening 56 and the contact surface of the spacer 54 . (57) Laterally moving systems. According to claim 1,
The contact surface 57 of the spacer 54 and the face surface 55 of the plunger head 52 are formed between the contact surface 57 and the face when the contact surface 57 and the face surface 55 come into contact with each other. A system that matches so that there is no space between the faces (55). 6. The method of claim 5,
and a lock automatically securing the safety slide (22) in the second position as the safety slide (22) enters the second position. 10. The method of claim 9,
and a visual indicator (65) on the safety slide (22) that is visible when the safety slide (22) enters the second position. A pre-filled syringe assembly (12) comprising a barrel (40), a plunger (50), and a seal (67), the plunger (50) comprising a plunger head (52), and an injector (15) comprising: held in the barrel (40) between the plunger head (52) and the seal (67);
a needle head (14) optionally attached to the pre-filled syringe assembly (12), the needle head (14) supporting a needle (16) comprising a sharp end (18) and a needle base (20); and
A tubular spacer 54 disposed on the needle head 14, the spacer 54 including a central opening 56 extending therethrough, the needle base 20 passing through the central opening 56 extended;
A needle and syringe system (10) comprising: 12. The method of claim 11,
and a safety slide (22) comprising a sheathing tube (30) surrounding a portion of the needle (16), wherein the safety slide (22) allows the sheathing tube (30) to attach to the sharp edge of the needle (16) relative to the needle 16 between a first position in which it does not extend beyond the end 18 and a second position in which the sheath tube 30 extends beyond the sharp end 18 of the needle 16 . movable system. 13. The method of claim 12,
When the plunger 50 is advanced inside the barrel 40 , the plunger head 52 moves the spacer 54 , and the spacer 54 moves the safety slide 22 to the first a system for moving from position to said second position. 12. The method of claim 11,
A system in which the needle head (14) pierces the thread (67) as the needle head (14) is attached to the pre-filled syringe barrel (40). 12. The method of claim 11,
The spacer (54) and the plunger head (52) coincide such that there is no space between the spacer (54) and the plunger head (52) when the spacer (54) and the plunger head (52) come into contact . 14. The method of claim 13,
A system in which the safety slide (22) is secured in the second position as the safety slide (22) enters the second position. 17. The method of claim 16,
and a visual indicator (65) on the safety slide (22) that is visible when the safety slide (22) enters the second position. 12. The method of claim 11,
and the needle head (14) includes a collar (34) selectively coupled to the barrel (40).

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